Foods which are ingested by humans include various components, such as carbohydrates, proteins, fats, vitamins and minerals. To digest food, the stomach secretes gastric juice which is primarily an aqueous solution of hydrochloric acid and pepsin. The acid serves to chemically break down food particles, to activate pepsin (which digests protein), to stimulate pancreatic secretion (which includes, inter alia, the enzyme lipase to digest fats), and to aid mineral absorption. Because fat particles are not soluble in the aqueous solution of the stomach, they remain relatively large as they pass from the stomach into the small intestine, i.e., into the duodenum.
The action of the enzyme lipase is not efficient on fat particles of a size which exit the stomach. When a particle has a large size, its ratio of surface area to mass is small. Since the digestive action of lipase starts at the particle surface, fat is more readily digested if the fat particles are broken up into smaller particles or globules having a relatively higher surface area-to-mass ratio.
Bile, a product of the liver, contains bile salts which emulsify fat, i.e., the bile salts act as a detergent to split fat particles in the diet into smaller globules so that they remain suspended in water in the form of an emulsion. This exposes substantially more of the fat surface area to the lipase so that the digestion process is enhanced. The liver continuously produces bile, which is stored in the gallbladder prior to delivery into the small intestine.
When a meal contains fat, the gastrointestinal tract secretes cholecystokinin, which in turn stimulates the gallbladder to introduce bile into the small intestine. The bile salts contained in the bile break up the ingested fat into smaller globules, attach to the globules, and facilitate the passage of the small fat globules, called micelles, into the lymphatic system and, consequently, into the blood stream for alteration of the fat by the liver.
In the past, it has been suggested that bile (for example, animal bile from bovine or porcine sources) be attached to non-biodegradable particles, such as collagen or cellulose, to provide a dietary supplement. It was thought that the fat released from food in an animal's stomach would become attached to the bile on the non-biodegradable particles, which then would pass through the intestinal tract and out from the body through body excreta, such as body stool. Provision of such a composition would enable fat in the diet to pass into the stool and not into the bloodstream, thereby reducing the amount of calories available for use by the body, resulting in weight loss and reduction of serum lipids, i.e., cholesterols, triglycerides, and free fatty acids.
In order for the non-biodegradable/bile composition to function effectively to carry fat particles through the gastrointestinal tract and out from the body, the bile salts must be permanently complexed or affixed to the non-biodegradable particles. If the bile salt is not permanently attached, the bile salt and associated fat micelles, instead of passing through the intestinal tract and out from the body, will be absorbed into the bloodstream through the intestinal mucosa.
It has been found that, with prior diet supplements that purport to incorporate bile bound to a non-biodegradable matrix, less bile is permanently affixed than desired. This results in inefficient removal of fat from the body.
There is a need, therefore, for a composition for use as a dietary supplement which is produced by a method which results in maximizing the amount of bile salts that are permanently affixed to a non-biodegradable substance.